FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
131089–131112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1989
PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR
K893199 · HNR
Allergan Medical Optics
Ophthalmic · 51d
Cleared Jun 16, 1989
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
K893737 · KTN
Quidel Corp.
Immunology · 30d
Cleared Jun 15, 1989
SHOWER STRETCHER W/WHEELS
K884759 · FPO
Linido, Inc.
General Hospital · 213d
Cleared Jun 15, 1989
INLINE AUTOTRANSFUSION SYSTEM
K890171 · CAC
Conmedcorp
Anesthesiology · 149d
Cleared Jun 15, 1989
ORTHORALIX SD/ORTHORALIX SD CEPH
K890351 · IZF
Philips Medical Systems North...
Radiology · 142d
Cleared Jun 15, 1989
CASPAR SCALP CLIP, APPLIER
K890443 · HBO
Aesculap Instruments Corp.
Neurology · 139d
Cleared Jun 15, 1989
BIVONA VENTILATOR ISOLATOR SYSTEM
K890499 · CAI
Bivona Medical Technologies
Anesthesiology · 134d
Cleared Jun 15, 1989
PREMISE SERIES BED
K890845 · FNL
Batesville American Mfg. Co.
General Hospital · 114d
Cleared Jun 15, 1989
BIOCHEM 520 BREATH INDICATOR
K890874 · CCK
Biochem International, Inc.
Anesthesiology · 114d
Cleared Jun 15, 1989
TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT
K891180 · DXP
Ingress Technologies, Inc.
Cardiovascular · 101d
Cleared Jun 15, 1989
MIC-100 WITH CRYOPROBES
K891282 · GEH
Frigitronics of Connecticut, Inc.
General & Plastic Surgery · 98d
Cleared Jun 15, 1989
KODAK EKTASCAN IMAGE MANAGER
K891690 · LMB
Eastman Kodak Company
Radiology · 85d
Cleared Jun 15, 1989
MAGNISCAN 5000 MR SYSTEM
K891769 · LNH
General Electric Co.
Radiology · 83d
Cleared Jun 15, 1989
RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
K891990 · LJB
Clinical Sciences, Inc.
Microbiology · 79d
Cleared Jun 15, 1989
SARNS MEDICAL CART
K892052 · LDQ
3M Company
General & Plastic Surgery · 78d
Cleared Jun 15, 1989
ISL QC 2000
K892058 · LXS
Intelligent Surgical Lasers, Inc.
Ophthalmic · 78d
Cleared Jun 15, 1989
CANDELA PLDL-1 PULSED DYE LASER
K892516 · GEX
Candela Laser Corp.
General & Plastic Surgery · 65d
Cleared Jun 15, 1989
KINETIC MODEL 700
K892808 · FSY
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 59d
Cleared Jun 15, 1989
HARVESTING TUBE
K892857 · CAC
Conmedcorp
Anesthesiology · 58d
Cleared Jun 15, 1989
AUTOMATIC CRANIAL DRILL (PERFORATOR)
K892866 · HBF
Acra Cut, Inc.
Neurology · 57d
Cleared Jun 15, 1989
CRADLE, HOSPITAL BED CLOTHING
K892877 · FNJ
Warsaw Orthopedic, Inc.
General Hospital · 57d
Cleared Jun 15, 1989
AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
K893707 · DRC
United States Surgical, A Division of...
Cardiovascular · 28d
Cleared Jun 15, 1989
COHERENT MARIE ARGON PHOTOCOAGULATOR
K893709 · HQF
Coherent Medical Group
Ophthalmic · 28d
Cleared Jun 14, 1989
ENTERAL FEEDING CONTAINER
K890424 · KNT
Multi-Med, Inc.
Gastroenterology & Urology · 139d